Stableline Tubing Organizer (Sterile)

Basic Information

• Brand Name: Stableline Tubing Organizer (Sterile)
• Primary DI: 00814321020209
• Version / Model: 5000S
• Company Name: INTERNATIONAL BIOPHYSICS CORPORATION
• Labeler DUNS: 788403103
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 7
• Public Version Date: 2021-12-15
• Public Version Status: Update
• Public Device Record Key: 99920646-7b5d-4619-9ed3-f4498f10b859
• Distribution End Date: 2021-12-14

Device Description

The Stableline is designed to stabilize and contain one to six tubing lines of varying sizes which connect cardiopulmonary bypass equipment for delivery or return of fluids to and from the surgical field. The product attaches to the surgical drapes and prevents the tubing lines from slipping, while keeping them out of the way of appropriate procedures. This component is a disposable, single use item.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	870.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62137	Medical/surgical interventional tube/cable securement clip, single-use	A device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814321020209	GS1